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CTRI Number  CTRI/2025/07/091530 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Mifepristone in various doses for treatment of uterine fibroid 
Scientific Title of Study   Evaluation of efficacy and safety of mifepristone in different doses in management of patients with uterine leiomyoma- a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Angela Sehra 
Designation  Senior consultant 
Affiliation  Maharaja Agarsen Hospital 
Address  Maharaja Agrasen Hospital 1, Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi

West
DELHI
110026
India 
Phone  7011959875  
Fax    
Email  asehra2006@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Jyotsna Puri 
Designation  Junior resident 
Affiliation  Maharaja Agrasen Hospital 
Address  Maharaja Agrasen Hospital 1, Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi

West
DELHI
110026
India 
Phone  7011959875  
Fax    
Email  jyotsnapuri1996@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jyotsna Puri 
Designation  Junior resident 
Affiliation  Maharaja Agrasen Hospital 
Address  Maharaja Agrasen Hospital 1, Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi

West
DELHI
110026
India 
Phone  7011959875  
Fax    
Email  jyotsnapuri1996@gmail.com  
 
Source of Monetary or Material Support  
Maharaja Agrasen Hospital, Punjabi Bagh, New Delhi, India Pincode- 110026 
 
Primary Sponsor  
Name  Jyotsna Puri 
Address  Maharaja Agrasen hospital, West Punjabi Bagh, New Delhi-110026 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyotsna Puri  Maharaja Agarsen Hospital  Department of obstetrics and gynecology, Maharaja Agrasen Hospital 1, Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi
West
DELHI 
7011959875

jyotsnapuri1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitonal Ethics Committee of Maharaja Agrasen Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tab Mifepristone   10 mg tablet will be given once daily for period of three months 
Intervention  Tablet Mifepristone  Dose of 25 mg to be given once daily for three months (based on clinical decision).  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1. Women between 20-50 years of age with single or multiple fibroids
2. Symptomatic (menorrhagia, polymenorrhea, dysmenorrhoea, abdominal lump, dull aching lower abdominal pain, dyspareunia) or
3. Asymptomatic 
 
ExclusionCriteria 
Details  1. USG suggestive of adenomyosis, endometriosis adnexal mass for the above symptoms.
2. More than 16-week gravid size uterus
3. Fibroids greater than 10 cm by ultrasound
4. Renal or hepatic dysfunction
5. Current genital infection
6. Endometrial hyperplasia with atypia
7. Hormonal medication (Progestogens or GnRH) within 3 months
8. Women desiring pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in symptoms after treatment in both groups
2. Change in Quality of life as assessed by Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire after treatment
3. Change in PBAC and Hemoglobin among both the groups
4. Change in size of uterine myoma on USG
 
at baseline and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of Adverse effects   At 3 moths 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   04/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Minimum 35 patients in each group with uterine fibroids attending gynaecology department of Maharaja Agrasen Hospital, New Delhi will be included in this study. Patients who did not meet the inclusion criteria will be excluded from the study. During first visit patients will be enrolled only after taking written inform consent & all demographic and clinical detail will be taken as per case record form. Further investigations would be done which are part of standard medical care advised to all fibroid patients, these includes, ABO/Rh grouping, Complete blood count (CBC) with ESR, hemoglobin, liver function tests (S.bilirubin, ALT & AST enzyme levels) and kidney function tests (Blood urea and serum creatinine). Trans-abdominal ultrasonography will be done for number, size and volume of myomas. PAP smear will be done to rule out any cervical pathology and endometrial biopsy to rule out any malignancy. Here, patients included in the study will be prescribed Tab mifepristone 10 mg or 25mg (based of clinical decision) once daily for 3 months.

A pictorial blood assessment chart (PBAC) chart will be given before starting treatment & during follow up after 3 months of treatment. UFS-QOL questionnaire will be administered. Patients will be counselled regarding possible side effects to mifepristone like headache, hot flushes, breast pain, fatigue, etc. Follow up would be done at 3 months of treatment and patients will be evaluated for decrease in bleeding by PBAC-Score, decrease in pain symptoms (abdomen pain, dysmenorrhoea, dyspareunia, pelvic pain and pressure symptoms) by visual analogue scale, assessment of hemoglobin, liver function and kidney function would be done, reduction in size of fibroid will be assessed by ultrasonography and change in quality of life by using UFS-QOL questionnaire. PAP smear and endometrial biopsy (if indicated) will be done.

 
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